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FDA Inspection
•Molecular Therapeutics LLC•September 10, 2025

Molecular Therapeutics LLC – FDA Inspection, Sep 10, 2025

Record Details

This FDA Inspection record concerns Molecular Therapeutics LLC, with an inspection on September 10, 2025, issued by the Atlanta District Office, covering medical devices & rad health.

Company
Molecular Therapeutics LLC
Inspection Date
September 10, 2025
Product Type
Medical Devices & Rad Health
Office
Atlanta District Office
Person
  • Dawn M. Braswell (Investigator)
View Company Profile

ID · 8d1803ac-e3c5-46a6-99a6-7b8c893b8652

Inspection Facts

No Action Indicated (NAI)

No objectionable conditions or practices were found during the inspection.

Inspection number
1281048
FDA center
Medical Devices & Rad Health
Project area
Postmarket Assurance: Medical Devices
Outcome
Form 483 issued, view the record

FDA Citations

3
  1. 21 CFR 820.100(a)Lack of or inadequate procedures
  2. 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
  3. 21 CFR 820.22Quality audits - Lack of or inadequate procedures

Full citation text and observation details available on the Dashboard.

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